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Trial registered on ANZCTR


Registration number
ACTRN12615000905561
Ethics application status
Approved
Date submitted
7/08/2015
Date registered
1/09/2015
Date last updated
23/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of the Dementia Care in Hospitals Program in improving the quality of life and adverse events in acute hospital patients with cognitive impairment: A stepped wedge cluster trial
Scientific title
Efficacy of an all of hospital staff, education and awareness program for cognitive impairment called the Dementia Care in Hospital Program versus usual care on quality of life and incidence rate of hospital acquired adverse events in acute hospital inpatients with cognitive impairment.
Secondary ID [1] 287244 0
Nil known
Universal Trial Number (UTN)
U1111-1172-9955
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital aquired adverse events 295852 0
Cognitive Impairment 295854 0
Delirium 295855 0
Dementia 295856 0
Condition category
Condition code
Neurological 296108 296108 0 0
Dementias
Injuries and Accidents 296109 296109 0 0
Other injuries and accidents
Public Health 296223 296223 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect of the DCHP will be measured in four different hospitals in Australia. The starting time for site 2,3 and 4 will be at 3 months intervals after site 1. Each site will have a 10week control period ( baseline data), a 4 week implementation period (no data collection) before a 12 month intervention period. The results will be pooled for final reporting.

The education component of the intervention is a face to face 15-30 min power-point provided by nurse educators to clinical and non-clinical staff focussing on good communication, re-orientation and carer engagement. The education will occur in the 3 months prior to implementation and continue throughout the interventation period for new staff to the target wards. The education is provided to all levels of clinical and non-clinical staff who may have contact with a pateint with Cognitive Impairment (CI).An education register is kept and it is expected that 80% of staff will be educated. Each hospital has selected between 5 -7 wards in their acute service. Intensive Care, Emergency and Peadiatrics are excluded.The awareness component is the use of an over bedside graphic called the Cognitive Impairment Identifier linked to positive screening for CI. The CII is copyrighted to Ballarat Health Service.
Intervention code [1] 292535 0
Prevention
Intervention code [2] 292536 0
Treatment: Other
Comparator / control treatment
Usual acute hospital care. This is care as required for hospital accreditation.Currently this is usually care targetting patients with CI who are percieved as disruptive on the ward. In such cirmcustances the patient may be "specialled" ( have additional 1 on 1 staff supervision) and the family asked to stay.
Control group
Active

Outcomes
Primary outcome [1] 295782 0
Frequency of nursing modifiable hospital aquired adverse, specifically pressure areas, pneumonia, delirium and urinary tract infections in patients aged 65 years and over identified with cognitive impairment.
The adverse event data will be collected using the existing hospital adverse event reporting systems. Health Round Table will collate the hospital data reporting on-
1. All patients admitted for multi-day stay aged 65 years and over (aged 50 years and over for ATSI status patients)
2. For all patients admitted for multi-day stay aged 65 years and over (aged 50 years and over for ATSI status patients):
a) Gender
b) Severity Index (Charlson Co-Morbidity excluding dementia)
c) Surgical Status
d) Adverse Events
Timepoint [1] 295782 0
At 3, 6, 9 and 12 months post the implementation period.
Secondary outcome [1] 316511 0
Change in patient quality of Life as measured by the DEMQoL
Timepoint [1] 316511 0
6 and 12 months post the implementation period.
Secondary outcome [2] 316512 0
Change staff knowledge about cognitive impairment and in staff perception of competence and of bother caring for patients with CI using a single study specific questionnaire.
Timepoint [2] 316512 0
6 and 12 months post inplementation.
Secondary outcome [3] 316513 0
Change in carer satisfaction using a study specific questionnaire.
Timepoint [3] 316513 0
6 and 12 months post inplementation.
Secondary outcome [4] 316993 0
Implementation cost and cost effectivness.
The primary economic evaluation will comprise a cost minimisation exercise. An analysis of costs and quality-of-life will also be undertaken to determine the ICER as the ratio of the mean cost difference between patients (aged 65+ with CI) in the pre- and post-implementation periods to the mean difference in DEMQOL score between patients (aged 65+ with CI) in the pre- and post-implementation period.
Timepoint [4] 316993 0
End of study

Eligibility
Key inclusion criteria
Cognitive impairment using a validated screening tool ( eg AMTS, mini-COG, AMT4, AT4). The tool used will be determined by the hospital.

Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Too unwell to complete the CI screening test and declines to participate in the DCHP. A consent waiver has been given for the collection of the adverse event data.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The choice as to which site went first was based on site organisational readiness. The wards are chosen by the site to include wards representative the inpatients group.All patients who meet all the inclusion criteria and none of the exclusion criteria will be included.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,SA,TAS,WA
Recruitment hospital [1] 4144 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 4145 0
The Canberra Hospital - Garran
Recruitment hospital [3] 4146 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 4147 0
Royal Hobart Hospital - Hobart

Funding & Sponsors
Funding source category [1] 291811 0
Government body
Name [1] 291811 0
Department of Health, Australian Government
Address [1] 291811 0
Tuggeranong Office Park
Soward Way (cnr Athllon Drive)
Greenway ACT 2900

PO Box 7576
Canberra Business Centre ACT 2610
Country [1] 291811 0
Australia
Primary sponsor type
Government body
Name
Ballarat Health Services
Address
Drummond Street North
Ballarat 3350
Victoria
Country
Australia
Secondary sponsor category [1] 290473 0
None
Name [1] 290473 0
Address [1] 290473 0
Country [1] 290473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293328 0
Ballarat and St John Of God HREC
Ethics committee address [1] 293328 0
1 Dummond Street North

Ballarat Central, Vic 3350
Ethics committee country [1] 293328 0
Australia
Date submitted for ethics approval [1] 293328 0
06/05/2015
Approval date [1] 293328 0
07/05/2015
Ethics approval number [1] 293328 0
HREC/15/BHSSJOG/13
Ethics committee name [2] 293329 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [2] 293329 0
Basil Hetzel Institute DX465101
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [2] 293329 0
Australia
Date submitted for ethics approval [2] 293329 0
15/03/2015
Approval date [2] 293329 0
05/06/2015
Ethics approval number [2] 293329 0
HREC/15/TQEH/9
Ethics committee name [3] 293330 0
Sir Charles Gairdner Group Human Research Ethics Committee (EC00271)
Ethics committee address [3] 293330 0
Sir Charles Gairdner Hospita
Hospital Avel
Nedlands
6009
WA
Ethics committee country [3] 293330 0
Australia
Date submitted for ethics approval [3] 293330 0
26/06/2015
Approval date [3] 293330 0
26/10/2015
Ethics approval number [3] 293330 0
2015-103
Ethics committee name [4] 293331 0
Tasmania Health & Medical Human Research Ethics Committee (EC00337)
Ethics committee address [4] 293331 0
Department of Health and Human Services
Level 2, Peacock Building
90 Davey Street
Hobart Tas 7000
Ethics committee country [4] 293331 0
Australia
Date submitted for ethics approval [4] 293331 0
17/02/2015
Approval date [4] 293331 0
17/03/2015
Ethics approval number [4] 293331 0
Ethics committee name [5] 295783 0
ACT Health Human Research Ethics Committee
Ethics committee address [5] 295783 0
PO Box 11
Woden
ACT 2606
Ethics committee country [5] 295783 0
Australia
Date submitted for ethics approval [5] 295783 0
05/06/2015
Approval date [5] 295783 0
22/07/2015
Ethics approval number [5] 295783 0
ETH.6.15.105

Summary
Brief summary
Dementia was the third leading cause of death in 2010, with 9,003 deaths recorded across Australia. For people aged 65 and over, dementia was the second leading cause of burden of disease and the leading cause of disability burden. Dementia is now the ninth National Health Priority Area in Australia.
Bail et al. (personal communication) from the Hospital dementia Services Project (2012) indicates that patient with dementia in medical and surgical services have 2.5 times increased risk of adverse event compared to the no dementia group matched for age and other comorbidities.
In the acute hospital setting patients can have difficulties with memory and thinking because of dementia or for other reasons such as delirium or specific brain injury such as stroke. Irrespective of the cause, disorders of memory and thinking or more succinctly Cognitive Impairment (CI) are a source of risk in the complex hospital environment.
While dementia can also occur in younger people, the current study will focus on patients in acute hospitals aged 65 and over with cognitive impairment as this is the largest hospital group.

Rationale for study:
It is recognised that hospital staff are not adequately equipped to identify or respond appropriately to people with dementia.
The Dementia Care in Hospitals Program (DCHP) is an all of hospital education program to improve communication with and awareness of patients with Cognitive Impairment (CI) linked to a bedside alert: the cognitive impairment identifier (CII). This program was first developed and introduced at BHS in 2004 in partnership with people with dementia and their families. The DCHP has been adopted by 25 public and private hospitals in Victoria. The program involves comprehensive training for clinical and non-clinical hospital staff.
Unpublished evaluations of the program found that 80% of staff reported it improved their practice and 40% reported that it had improved their response to carers. Carers also reported greater satisfaction with the care their family member received (AIHW 2013). However, while staff perceptions and carer and patient satisfaction were measured, the effect of the DCHP on clinical outcomes such as adverse events and cost effectiveness has not been measured.
The Department of Social Services has now funded a roll-out of the DCHP to other Australian jurisdictions and requested a national evaluation which is the basis for this study. There are three interrelated but separate elements to the evaluation that is the subject of this protocol-
1. Change in patient quality of life, carer satisfaction and staff knowledge and perceived difficulty with care
2. Change in nursing modifiable adverse events in patients over 65 with cognitive impairment
3. Cost effectiveness of the DCHP
Element (2) is the basis for a PhD to be completed by A/Prof Mark Yates
Trial website
Trial related presentations / publications
The Dementia Care in Hospitals Program- Protocal for National Evaluation and Roll Out
Poster Presemtation
NHMRC National Institute for Dementia Reseach Symposium May 2016.
A/Prof Mark Yates
See attachment on ANZCTR registration form
Public notes
Attachments [1] 1054 1054 0 0

Contacts
Principal investigator
Name 59402 0
A/Prof Mark Yates
Address 59402 0
Ballarat Health Services
Drummond St North
Ballarat 3350
Victoria
Country 59402 0
Australia
Phone 59402 0
+61 3 53203704
Fax 59402 0
Email 59402 0
mark.yates@bhs.org.au
Contact person for public queries
Name 59403 0
A/Prof Mark Yates
Address 59403 0
Ballarat Health Services
Drummond St North
Ballarat 3350
Victoria
Country 59403 0
Australia
Phone 59403 0
+61 3 53203704
Fax 59403 0
Email 59403 0
mark.yates@bhs.org.au
Contact person for scientific queries
Name 59404 0
A/Prof Mark Yates
Address 59404 0
Ballarat Health Services
Drummond St North
Ballarat 3350
Victoria
Country 59404 0
Australia
Phone 59404 0
+61 3 53203704
Fax 59404 0
Email 59404 0
mark.yates@bhs.org.au

No information has been provided regarding IPD availability
Summary results
No Results